CLASS II Drug recall · Reported 22 Apr 2020 · FDA Enforcement Report
Phentermine Hydrochloride Capsules, USP 15mg recalled
Aurobindo Pharma USA is recalling Phentermine Hydrochloride Capsules, USP 15mg, distributed nationwide in the US. The recall was initiated on 18 Mar 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1236-2020
- FDA event ID
- 85183
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Phentermine
- Manufacturer
- Aurolife Pharma, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2020
- FDA classified
- 13 Apr 2020
- Reported
- 22 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 18 Mar 2020 | Recall initiated by company | |
| 13 Apr 2020 | Classified by FDA | +26 days |
| 22 Apr 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product as listed by the FDA
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Phentermine Hydrochloride Capsules, USP 15mg recalled?
Yes. Aurobindo Pharma USA recalled Phentermine Hydrochloride Capsules, USP 15mg on 18 Mar 2020. The recall is Class II and its status is Terminated. Recall number D-1236-2020.
Why was it recalled?
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Which lots are affected?
Lot #: 105180004A, Exp. Date 03/2020
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aurobindo Pharma USA
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Phentermine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phentermine Hydrochloride Capsules, USP 30mg recalled by KVK TechPhentermine Hydrochloride | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Phentermine Capsules, 15 mg, a) bottle recalled by PD-Rx PharmaceuticalsPhentermine Hydrochloride | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Phentermine HCL Capsules, USP 15 mg recalled by KVK-TechPhentermine Hydrochloride | KVK-Tech | Potency & Assay | Nationwide |
| Drug | CLASS III | Phentermine Hydrochloride Capsules, USP, 15 mg recalledPhentermine Hydrochloride | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Phentermine Hydrochloride Capsules, USP, 15 mg recalled by KVK-Tech | KVK-Tech | Potency & Assay | Nationwide |